QUALITY-OF-LIFE ASSESSMENT IN PEDIATRIC ONCOLOGY - A RETROSPECTIVE REVIEW OF PHASE-III REPORTS

Background: although the quality of life of cancer patients has been a topic of increasing interest, the research literature to date has gen erally noted minimal reporting of these data in adult clinical trials. Purpose: the purpose of this investigation was to examine the frequen cy with which these measures are reported in pediatric cancer clinical trials. Method: published reports of 70 Phase III clinical trials fro m the Pediatric Oncology Group and Childrens Cancer Group were reviewe d for presentation of quality of life and toxicity data. Results: appr oximately 3% of these reports included quality of life data, while tox icities were noted for over 75%. Conclusions: quality of life endpoint s are not reflected in clinical trial reports. Education as to the pot ential usefulness of these data, as well as recognition of the barrier s that exist to using such measures must be addressed.